Nitric Oxide Lung Diffusing Capacity in Healthy, Non-smoking Adults

NCT04016597 | Completed

• 1 other identifier: 2019-00226
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The measurement of nitric oxide lung diffusing capacity (DLNO) has been recently standardised. To date, two pulmonary function devices are commercially available and are used for the measurement of DLNO. No previous study assessed differences in gas exchange outcomes (e.g., DLNO values) between both devices. The aim of this project is to compare two commercially available devices that measure lung diffusing capacity for nitric oxide (DLNO).

1. 1."MasterScreenTM" (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany
2. 2."HypAir" ("HA", Medisoft, Dinant, Belgium).

Conditions

Healthy

Keywords

diffusing capacity; reliability; healthy; adults; nitric oxide

Outcome Measures

Primary Outcomes (1)

• Difference in nitric oxide lung diffusing capacity (mL/min/mmHg)

  Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).

  1 hour

Secondary Outcomes (12)

• Difference in carbon monoxide lung diffusing capacity (mL/min/mmHg)

  1 hour

• Difference in Alveolar volume (L)

  1 hour

• Difference in inspiratory volume (L)

  1 hour

• Difference in breath-hold time (s)

  1 hour

• Difference in inspired concentrations for nitric oxide (in %)

  1 hour

Study Arms (1)

Lung diffusing capacity measurements

Participants perform single-breath lung diffusing capacity measurements in random order during one study visit.

Device: Jaeger Masterscreen TM; Device: HypAir Medisoft

Interventions

Jaeger Masterscreen TM DEVICE

Single-breath nitric oxide lung diffusing capacity

Lung diffusing capacity measurements

HypAir Medisoft DEVICE

Single-breath nitric oxide lung diffusing capacity

Lung diffusing capacity measurements

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy people

You may qualify if:

• \- Age 18 years and older

You may not qualify if:

• Previous thoracic surgery
• Smoking
• Chronic lung disease (e.g., asthma bronchiale, COPD)
• Forced expiratory volume in 1s and/or forced vital capacity below the lower limit of normal based on spirometry \[Quanjer et al. Eur Respir J 2005\]
• Current respiratory infection

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University of Zurich and University Hospital of Zurich

Zurich, 8001, Switzerland

Location

Related Publications (1)

• Zavorsky GS, Hsia CC, Hughes JM, Borland CD, Guenard H, van der Lee I, Steenbruggen I, Naeije R, Cao J, Dinh-Xuan AT. Standardisation and application of the single-breath determination of nitric oxide uptake in the lung. Eur Respir J. 2017 Feb 8;49(2):1600962. doi: 10.1183/13993003.00962-2016. Print 2017 Feb.

  PMID: 28179436 RESULT

Study Officials

• Thomas Radtke, PhD

  University of Zurich, EBPI, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2019
• First Posted: July 11, 2019
• Study Start: October 1, 2019
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: February 11, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)